Controller General of Patents, Designs and Trademarks, India has issued draft guidelines for patent examiners and controllers for the purpose of screening, allotment and examination of patent applications relating to Traditional Knowledge and /or biological materials. Suggestions/Comments in this regard have been invited till 22nd of November. As per the guidelines, the Receipt, EDP, Classification and Screening (RECS) Section has to classify all such patent applications as “Traditional Knowledge” and in case of any inappropriate classification, reclassification has to be done by technical head.

The draft proposes six ‘Guiding Principles’ for the purpose of assessment of novelty and inventive step. While, for the purpose of novelty, it is proposed that claim relating to extracts or isolation of active ingredients of plants, which are naturally/inherently present in plants, should not be considered as novel over teachings of Traditional Knowledge, in case of inventive step, combination of plants with same known therapeutic agents should be considered to be obvious. Similarly a combination of ingredients for treatment of a disease is presumed to be obvious if at least one of the ingredients is known as traditional knowledge to be effective in treating the disease. The guidelines also state that the selection of a single ingredient from amongst a combination of ingredients known for their therapeutic effect as per traditional knowledge is not inventive. Also the determination of, by routine experiments, optimum or workable ranges of traditionally known ingredients is not inventive.

The draft guidelines also state that patent should not be granted unless the permission of National Biodiversity Authority is submitted in case biological material from India has been used. The draft guidelines were necessary to avoid grant of patents on use of Traditional Knowledge of India principally in Ayurveda, Unani and Siddha systems of medicine and in case of inventions relating to biological resources.

It is noteworthy that the guidelines have been issued shortly after the government exercised its powers under Section 66 of The Patents Act, 1970 to revoke the patent granted to ‘a synergistic ayurvedic/functional food bioactive’ to treat diabetes, as being generally prejudicial to public interest.